--- title: Neoadjuvant Darovasertib in Primary Uveal Melanoma nct_id: NCT07015190 overall_status: RECRUITING phase: PHASE3 sponsor: IDEAYA Biosciences study_type: INTERVENTIONAL primary_condition: Uveal Melanoma countries: United States, Australia, Austria, Belgium, Canada, Czechia, Denmark, Estonia, France, Germany, Greece, Israel, Italy, Netherlands, New Zealand, Poland, Slovakia, Slovenia, Spain, Switzerland, United Kingdom canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07015190.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07015190" ct_last_update_post_date: 2026-05-06 last_seen_at: "2026-05-12T06:06:41.385Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Neoadjuvant Darovasertib in Primary Uveal Melanoma **Official Title:** A Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects With Primary Non-metastatic Uveal Melanoma (OptimUM-10) **NCT ID:** [NCT07015190](https://clinicaltrials.gov/study/NCT07015190) ## Key Facts - **Status:** RECRUITING - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 520 - **Lead Sponsor:** IDEAYA Biosciences - **Conditions:** Uveal Melanoma - **Start Date:** 2026-01-25 - **Completion Date:** 2031-03 - **CT.gov Last Update:** 2026-05-06 ## Brief Summary This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10) ## Detailed Description The study is divided into 2 cohorts of patients with primary uveal melanoma requiring either plaque brachytherapy or enucleation. In cohort 1, patients in the treatment arm will receive neoadjuvant darovasertib followed by plaque brachytherapy compared to immediate plaque brachytherapy (control arm). In cohort 2, the treatment arm will receive neoadjuvant darovasertib followed by definitive primary local therapy (i.e., plaque brachytherapy, proton beam radiation, or enucleation). Subjects in the control arm will go onto immediate enucleation. Subjects will then receive primary local therapy following neoadjuvant darovasertib. All patients will be followed for up to 3 years to assess longer term outcomes such as vision and tumor recurrence. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Primary non-metastatic uveal melanoma * Able and willing to provide written, informed consent before initiation of any study-related procedures, and in the opinion of the Investigator, to comply with all study requirements * ECOG 0 or 1 * Adequate organ function Exclusion Criteria: * Previous treatment for UM * Evidence of metastatic UM * Attributes that necessitate enucleation regardless of response to therapy * Evidence of progressive secondary underlying ocular disease that would confound longitudinal VA assessments * Presence of a malignant disease other than the one being treated in this study ``` ## Arms - **Treatment Arm** (EXPERIMENTAL) — Darovasetib followed by definitive primary local therapy (i.e., PB, proton beam radiation, or enucleation) - **Control Arm** (ACTIVE_COMPARATOR) — Immediate Primary Local therapy ## Interventions - **Darovasertib** (DRUG) — Dosed orally, twice daily (28-day/ cycle - **Primary Local Therapy** (PROCEDURE) — Plaque Brachytherapy or Enucleation ## Primary Outcomes - **Cohort 1: To demonstrate that the proportion of subjects with vision loss is lower for subjects in the Treatment Arm vs the Control Arm** _(time frame: Approximately 3 years)_ — Loss of Best Corrected Visual Acuity (BCVA) of ≥ 15 letters using Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA - **Cohort 2: To demonstrate the ability to salvage the eye and prevent enucleation in the Treatment Arm** _(time frame: Approximately 2 years)_ — Eye preservation rate ## Locations (94) - Mayo Clinic Scottsdale - PPDS, Scottsdale, Arizona, United States — _RECRUITING_ - UCSD Moores Cancer Center, La Jolla, California, United States — _NOT_YET_RECRUITING_ - Jules Stein Eye Institute, Los Angeles, California, United States — _NOT_YET_RECRUITING_ - USC Norris Comprehensive Cancer Center, Los Angeles, California, United States — _NOT_YET_RECRUITING_ - University of California Irvine Medical Center, Orange, California, United States — _NOT_YET_RECRUITING_ - Stanford Comprehensive Cancer Center, Palo Alto, California, United States — _RECRUITING_ - Kaiser Permanente-Riverside Medical Center, Riverside, California, United States — _RECRUITING_ - UCSF Wayne and Gladys Valley Center for Vision, San Francisco, California, United States — _NOT_YET_RECRUITING_ - University of Colorado Hospital, Aurora, Colorado, United States — _RECRUITING_ - The Melanoma and Skin Cancer Institute, Englewood, Colorado, United States — _NOT_YET_RECRUITING_ - Mayo Clinic Jacksonville, Jacksonville, Florida, United States — _RECRUITING_ - USF Health Eye Institute, Tampa, Florida, United States — _NOT_YET_RECRUITING_ - Moffit Cancer Center, Tampa, Florida, United States — _NOT_YET_RECRUITING_ - Wilmer Eye Institute, Baltimore, Maryland, United States — _RECRUITING_ - Massachusetts General Hospital, Boston, Massachusetts, United States — _NOT_YET_RECRUITING_ - W Kellogg Eye Center, Ann Arbor, Michigan, United States — _NOT_YET_RECRUITING_ - The Cancer and Hematology Centers of West Michigan (CHCWM), Grand Rapids, Michigan, United States — _RECRUITING_ - Mayo Clinic - PPDS, Rochester, Minnesota, United States — _RECRUITING_ - TIERING Percentiles, Omaha, Nebraska, United States — _NOT_YET_RECRUITING_ - Herbert Irving Comprehensive Cancer Center, New York, New York, United States — _RECRUITING_ - Memorial Sloan Kettering Cancer Center - 1275 York Ave, New York, New York, United States — _NOT_YET_RECRUITING_ - Northwell Health Cancer Institute, New York, New York, United States — _NOT_YET_RECRUITING_ - Cole Eye Institute-9500 Euclid Ave, Cleveland, Ohio, United States — _NOT_YET_RECRUITING_ - Ohio State Eye and Ear Institute, Columbus, Ohio, United States — _NOT_YET_RECRUITING_ - Retina Consultants of Oklahoma, Oklahoma City, Oklahoma, United States — _NOT_YET_RECRUITING_ - Jefferson Health Honickman Center, Philadelphia, Pennsylvania, United States — _NOT_YET_RECRUITING_ - UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States — _NOT_YET_RECRUITING_ - SCRI Oncology Partners, Nashville, Tennessee, United States — _RECRUITING_ - Vanderbilt Eye Institute, Nashville, Tennessee, United States — _NOT_YET_RECRUITING_ - Austin Retina Associates - Central, Austin, Texas, United States — _RECRUITING_ - Texas Retina Associates - Dallas, Dallas, Texas, United States — _RECRUITING_ - University of Texas Southwestern Medical Center-5323 Harry Hines Blvd, Dallas, Texas, United States — _RECRUITING_ - Retina Consultants of Texas - (Houston), Houston, Texas, United States — _NOT_YET_RECRUITING_ - Augusta Health, Center for Cancer and Blood Disorders, Fishersville, Virginia, United States — _NOT_YET_RECRUITING_ - University of Wisconsin Health, Madison, Wisconsin, United States — _NOT_YET_RECRUITING_ - Gallipoli Medical Research Foundation, Greenslopes, Queensland, Australia — _NOT_YET_RECRUITING_ - The Queen Elizabeth Hospital, Woodville South, South Australia, Australia — _NOT_YET_RECRUITING_ - The Alfred Hospital, Melbourne, Victoria, Australia — _NOT_YET_RECRUITING_ - The Crown Princess Mary Cancer Centre (Westmead Hospital), NSW 214, Westmead, Australia — _NOT_YET_RECRUITING_ - LKH-Universitätsklinikum Graz, Graz, Austria — _NOT_YET_RECRUITING_ - Universitätsklinikum Innsbruck, Innsbruck, Austria — _NOT_YET_RECRUITING_ - Universitätsklinikum AKH Wien, Vienna, Austria — _NOT_YET_RECRUITING_ - Cliniques Universitaires Saint-Luc - PPDS, Brussels, Belgium — _RECRUITING_ - UZ Leuven - PPDS, Leuven, Belgium — _NOT_YET_RECRUITING_ - Cross Cancer Institute, Edmonton, Alberta, Canada — _NOT_YET_RECRUITING_ - Princess Margaret Cancer Centre, Toronto, Ontario, Canada — _RECRUITING_ - Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha, Prague, Prague, Czechia — _RECRUITING_ - Rigshospitalet, Copenhagen O, Capital, Denmark — _NOT_YET_RECRUITING_ - Aarhus Universitetshospital, Aarhus, Central Jutland, Denmark — _NOT_YET_RECRUITING_ - East Tallinn Central Hospital-Pärnu road 104, Tallinn, Harju, Estonia — _NOT_YET_RECRUITING_ - CHU de Nice-Hôpital Pasteur, Nice, Alpes-Maritimes, France — _NOT_YET_RECRUITING_ - Centre Retine Gallien - Bordeaux, Bordeaux, Gironde, France — _NOT_YET_RECRUITING_ - CHU de Rennes - Hôpital Pontchaillou, Rennes, Ille-et-Vilaine, France — _NOT_YET_RECRUITING_ - Institut Curie - Hôpital de Paris, Paris, Paris, France — _NOT_YET_RECRUITING_ - Centre Hospitalier National D'ophtalmologie Des Quinze Vingts, Paris, France — _NOT_YET_RECRUITING_ - Universitätsklinikum Tübingen, Tübingen, Baden-Wurttemberg, Germany — _NOT_YET_RECRUITING_ - Universitätsklinikum Ulm, Ulm, Baden-Wurttemberg, Germany — _NOT_YET_RECRUITING_ - Hautklinik Erlangen, Erlangen, Bavaria, Germany — _NOT_YET_RECRUITING_ - Universitätsklinikum Essen, Essen, North Rhine-Westphalia, Germany — _NOT_YET_RECRUITING_ - Städtisches Klinikum Dessau, Dessau, Saxony-Anhalt, Germany — _NOT_YET_RECRUITING_ - Charité - Universitätsmedizin Berlin, Berlin, Germany — _NOT_YET_RECRUITING_ - Universitätsklinikum Bonn, Bonn, Germany — _NOT_YET_RECRUITING_ - Universitätsklinikum Schleswig-Holstein - Campus Lübeck, Lübeck, Germany — _NOT_YET_RECRUITING_ - Universitätsklinikum Giessen und Marburg - Marburg (UKGM), Marburg, Germany — _NOT_YET_RECRUITING_ - Universitätsklinikum Würzburg, Würzburg, Germany — _NOT_YET_RECRUITING_ - PAGNI-University General Hospital of Heraklion, Heraklion, Irakleio, Greece — _NOT_YET_RECRUITING_ - University General Hospital of Larissa, Larissa, Larissa, Greece — _NOT_YET_RECRUITING_ - AHEPA University General Hospital of Thessaloniki, Thessaloniki, Thessaloníki, Greece — _NOT_YET_RECRUITING_ - The Chaim Sheba Medical Center - PPDS, Ramat Gan, Central District, Israel — _RECRUITING_ - Hadassah Medical Center - PPDS, Jerusalem, Jerusalem, Israel — _RECRUITING_ - Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale, Naples, Campania, Italy — _NOT_YET_RECRUITING_ - ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco, Milan, Milan, Italy — _NOT_YET_RECRUITING_ - Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia, Perugia, Perugia, Italy — _NOT_YET_RECRUITING_ - Azienda Ospedaliera Universitaria Careggi, Florence, Tuscany, Italy — _RECRUITING_ - Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia, Pisa, Italy — _NOT_YET_RECRUITING_ - Fondazione Policlinico Universitario A Gemelli - Rome - PPDS, Rome, Italy — _NOT_YET_RECRUITING_ - Erasmus MC, Rotterdam, South Holland, Netherlands — _NOT_YET_RECRUITING_ - Auckland Eye, Auckland, Auckland, New Zealand — _NOT_YET_RECRUITING_ - Uniwersytecki Szpital Kliniczny w Poznaniu- Dluga 1/2, Poznan, Greater Poland Voivodeship, Poland — _NOT_YET_RECRUITING_ - WIM-PIB, Centralny Szpital Kliniczny MON, Warsaw, Masovian Voivodeship, Poland — _NOT_YET_RECRUITING_ - Uniwersyteckie Centrum Kliniczne w Gdansku - Debinki 7, Gdansk, Pomeranian Voivodeship, Poland — _NOT_YET_RECRUITING_ - Fakultna nemocnica s poliklinikou F. D. Roosevelta, Banská Bystrica, Slovakia — _NOT_YET_RECRUITING_ - Institute of Oncology Ljubljana, Ljubljana, Ljubljana, Slovenia — _NOT_YET_RECRUITING_ - Hospital Clinico Universitario de Santiago, Santiago de Compostela, A Coruña, Spain — _RECRUITING_ - Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain — _NOT_YET_RECRUITING_ - Clinica Universidad Navarra, Pamplona, Navarre, Spain — _RECRUITING_ - Hospital Universitari i Politecnic La Fe de Valencia, Valencia, Valencia, Spain — _NOT_YET_RECRUITING_ - Hospital Clinico Universitario de Valladolid, Valladolid, Valladolid, Spain — _RECRUITING_ - Hospital Universitario Virgen Macarena, Seville, Spain — _RECRUITING_ - Universitätsspital Basel, Basel, Switzerland — _RECRUITING_ - Universitätsspital Zürich, Zurich, Switzerland — _RECRUITING_ - Clatterbridge Cancer Centre - Liverpool - NWCRN - PPDS, Metropolitan Borough of Wirral, Merseyside, United Kingdom — _NOT_YET_RECRUITING_ - University College Hospital, London, United Kingdom — _NOT_YET_RECRUITING_ - Weston Park Cancer Centre - PPDS, Sheffield, United Kingdom — _NOT_YET_RECRUITING_ ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.mayo clinic scottsdale - ppds|scottsdale|arizona|united states` — added _(2026-05-12)_ - `locations.ucsd moores cancer center|la jolla|california|united states` — added _(2026-05-12)_ - `locations.jules stein eye institute|los angeles|california|united states` — added _(2026-05-12)_ - `locations.usc norris comprehensive cancer center|los angeles|california|united states` — added _(2026-05-12)_ - `locations.university of california irvine medical center|orange|california|united states` — added _(2026-05-12)_ - `locations.stanford comprehensive cancer center|palo alto|california|united states` — added _(2026-05-12)_ - `locations.kaiser permanente-riverside medical center|riverside|california|united states` — added _(2026-05-12)_ - `locations.ucsf wayne and gladys valley center for vision|san francisco|california|united states` — added _(2026-05-12)_ - `locations.university of colorado hospital|aurora|colorado|united states` — added _(2026-05-12)_ - `locations.the melanoma and skin cancer institute|englewood|colorado|united states` — added _(2026-05-12)_ - `locations.mayo clinic jacksonville|jacksonville|florida|united states` — added _(2026-05-12)_ - `locations.usf health eye institute|tampa|florida|united states` — added _(2026-05-12)_ - `locations.moffit cancer center|tampa|florida|united states` — added _(2026-05-12)_ - `locations.wilmer eye institute|baltimore|maryland|united states` — added _(2026-05-12)_ - `locations.massachusetts general hospital|boston|massachusetts|united states` — added _(2026-05-12)_ - `locations.w kellogg eye center|ann arbor|michigan|united states` — added _(2026-05-12)_ - `locations.the cancer and hematology centers of west michigan (chcwm)|grand rapids|michigan|united states` — added _(2026-05-12)_ - `locations.mayo clinic - ppds|rochester|minnesota|united states` — added _(2026-05-12)_ - `locations.tiering percentiles|omaha|nebraska|united states` — added _(2026-05-12)_ - `locations.herbert irving comprehensive cancer center|new york|new york|united states` — added _(2026-05-12)_ - `locations.memorial sloan kettering cancer center - 1275 york ave|new york|new york|united states` — added _(2026-05-12)_ - `locations.northwell health cancer institute|new york|new york|united states` — added _(2026-05-12)_ - `locations.cole eye institute-9500 euclid ave|cleveland|ohio|united states` — added _(2026-05-12)_ - `locations.ohio state eye and ear institute|columbus|ohio|united states` — added _(2026-05-12)_ - `locations.retina consultants of oklahoma|oklahoma city|oklahoma|united states` — added _(2026-05-12)_ - `locations.jefferson health honickman center|philadelphia|pennsylvania|united states` — added _(2026-05-12)_ - `locations.upmc hillman cancer center|pittsburgh|pennsylvania|united states` — added _(2026-05-12)_ - `locations.scri oncology partners|nashville|tennessee|united states` — added _(2026-05-12)_ - `locations.vanderbilt eye institute|nashville|tennessee|united states` — added _(2026-05-12)_ - `locations.austin retina associates - central|austin|texas|united states` — added _(2026-05-12)_ - `locations.texas retina associates - dallas|dallas|texas|united states` — added _(2026-05-12)_ - `locations.university of texas southwestern medical center-5323 harry hines blvd|dallas|texas|united states` — added _(2026-05-12)_ - `locations.retina consultants of texas - (houston)|houston|texas|united states` — added _(2026-05-12)_ - `locations.augusta health, center for cancer and blood disorders|fishersville|virginia|united states` — added _(2026-05-12)_ - `locations.university of wisconsin health|madison|wisconsin|united states` — added _(2026-05-12)_ - `locations.gallipoli medical research foundation|greenslopes|queensland|australia` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT07015190.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT07015190* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*